Daiichi Sankyo and AstraZeneca Announce First Positive Phase III Results for TROP2 ADC Datopotamab Deruxtecan in HR-Positive, HER2-Negative Metastatic Breast Cancer

Intelligent Finance APP learned on September 22 that Daiichi Sankyo and AstraZeneca (AZN.US) jointly announced that the TROP2 ADC Dato-DXd (DS-1062) had reached the primary endpoint of PFS in the Phase III clinical trial, TROPION-Breast01 study, for unresectable or metastatic HR-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer patients who have previously received endocrine therapy and at least one systemic therapy.

It is reported that this is the first Phase III clinical trial of Dato-DXd in breast cancer to announce results. Following the positive outcomes of the trial, the two companies plan to submit corresponding marketing applications to global regulatory authorities. In the field of breast cancer, the drug has two additional Phase III clinical trials underway: TROPION-Breast02 for first-line treatment of triple-negative breast cancer and TROPION-Breast03 for adjuvant treatment of triple-negative breast cancer.

Notably, in July this year, Dato-DXd just achieved the first positive results from a Phase III clinical trial. TROPION-Lung01, targeting advanced NSCLC, also met its primary endpoint of PFS. Additionally, there are two more Phase III clinical trials covering first-line NSCLC: TROPION-Lung07 and TROPION-Lung08. These studies are exploring the combination regimen of Dato-DXd with pembrolizumab (Keytruda), which is highly anticipated.